Class I — UrgentReported 2025-02-05

Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of Japan, Distributed by: Astellas Pharma US Inc., Northbrook, IL 60062, NDC 0469-0647-73.

Reason for Recall

Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules

Recall Number

D-0210-2025

Classification

Class I

Status

Ongoing